BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE FLOPPY II GUIDE WIRE

    MDR report key: 385213 · Received March 28, 2002

    Report

    Report Number
    2024168-2002-00114
    Event Type
    Injury
    Date Received
    March 28, 2002
    Date of Event
    January 24, 2002
    Report Date
    February 27, 2002
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, A BMW GUIDE WIRE WAS ADVANCED TO A LESION IN THE CIRCUMFLEX, BUT WOULD NOT CROSS. THE GUIDE WIRE WAS THEREFORE REDIRECTED DOWN THE LAD. THE HI-TORQUE FLOPPY (HTF) WAS THEN ADVANCED DOWN THE CIRCUMFLEX, AND THE LEFT ANTERIOR DESCENDING ARTERY WAS STENTED. REPORTEDLY, THE HTF WAS PLACED IN THE CIRCUMFLEX FOR BACK UP ONLY. WHEN THE GUIDE WIRES WERE PULLED OUT, SLIGHT RESISTANCE WAS FELT UPON REMOVAL AND IT WAS NOTED THAT THE TIP OF THE HTF REMAINED IN THE DISTAL CIRCUMFLEX. THE TIP REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE FLOPPY II GUIDE WIRE GUIDE WIRE DQX GUIDANT VASCULAR INTERVENTION NA 1031551

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Disability MEDTRONIC 7F.| DILATATION CATHETER: J.L. GUIDE WIRE:BMW/HTF EXTRA| CATHETER: WISE GUIDE 7L4: RHV: BOSTON: SHEATH:| S.: INFLATION DEVICE: EVEREST MEDTRONIC, GUIDING